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Completed

NCT Number: NCT04736576

Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy

The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC).

Patients will be enrolled into either palbociclib plus endocrine therapy group (Group 1) or endocrine monotherapy group (Group 2) based on the discretion of the treating physician under routine clinical practice. Total target number of patients is approximately one-hundred in this study (About 50 patients in each group).

Enrolled patients will download a smartphone-based application for electronic PRO (ePRO), be provided access to and trained on the use of the application to complete baseline, weekly, and cycle-based assessments for 6 cycles (24 weeks). In addition, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aichi Cancer Center Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult women (≥ 20 years of age)
  • Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to resection or radiation therapy with curative intent.
  • Documented evidence of HR+/HER2- tumor based on the patient's surgical specimen or most recent tumor biopsy.
  • Initiating first or second line treatment at study entry with one of the following therapies:

palbociclib plus endocrine therapy or endocrine monotherapy

  • Eastern Cooperative Oncology Group (ECOG) performance status = 0~1.
  • Owns or has regular access to an Apple iPhone or Android phone.
  • Willing and able to complete collection of data via smartphone-based application.
  • Willing and able to wear the wearable device for approximately 6 months.
  • Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
  • Able to read and understand Japanese

Exclusion criteria

  • The patient is participating in any interventional clinical trial that includes investigational or marketed products. Patients participating in other investigator-initiated research or non-interventional studies can be included as long as their standard of care is not altered by the study.
  • The patient is on active treatment for other malignancies other than ABC.
  • The patient's life style is fluctuating in weekly-basis (eg, shift-time worker), which may have high impact on physical activity assessment based to investigator's discretion

Treatment and study plan

wearable device

Device

As a low-interventional procedure, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).

Primary outcomes

  1. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (Items) [EORTC-QLQ-C30] Global Health Status (GHS) Sub-scale Score for Cycle 1

    Time frame: Baseline, Cycle 1 (1 cycle = 4 Weeks)

    The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' quality of life (QOL), and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health status scale (GHS)/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

  2. Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 2

    Time frame: Baseline, Cycle 2 (1 cycle = 4 weeks)

    The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

  3. Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 3

    Time frame: Baseline, Cycle 3 (1 cycle = 4 Weeks)

    The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

  4. Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4

    Time frame: Baseline, Cycle 4 (1 cycle = 4 Weeks)

    The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

  5. Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5

    Time frame: Baseline, Cycle 5 (1 cycle = 4 Weeks)

    The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

  6. Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6

    Time frame: Baseline, Cycle 6 (1 cycle = 4 Weeks)

    The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

  7. Change From Baseline in Sedentary Time Wearing at Week 1

    Time frame: Baseline, Week 1

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  8. Change From Baseline in Sedentary Time Wearing at Week 2

    Time frame: Baseline, Week 2

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  9. Change From Baseline in Sedentary Time Wearing at Week 3

    Time frame: Baseline, Week 3

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  10. Change From Baseline in Sedentary Time Wearing at Week 4

    Time frame: Baseline, Week 4

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  11. Change From Baseline in Sedentary Time Wearing at Week 5

    Time frame: Baseline, Week 5

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  12. Change From Baseline in Sedentary Time Wearing at Week 6

    Time frame: Baseline, Week 6

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  13. Change From Baseline in Sedentary Time Wearing at Week 7

    Time frame: Baseline, Week 7

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  14. Change From Baseline in Sedentary Time Wearing at Week 8

    Time frame: Baseline, Week 8

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  15. Change From Baseline in Sedentary Time Wearing at Week 9

    Time frame: Baseline, Week 9

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  16. Change From Baseline in Sedentary Time Wearing at Week 10

    Time frame: Baseline, Week 10

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  17. Change From Baseline in Sedentary Time Wearing at Week 11

    Time frame: Baseline, Week 11

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  18. Change From Baseline in Sedentary Time Wearing at Week 12

    Time frame: Baseline, Week 12

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  19. Change From Baseline in Sedentary Time Wearing at Week 13

    Time frame: Baseline, Week 13

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  20. Change From Baseline in Sedentary Time Wearing at Week 14

    Time frame: Baseline, Week 14

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  21. Change From Baseline in Sedentary Time Wearing at Week 15

    Time frame: Baseline, Week 15

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  22. Change From Baseline in Sedentary Time Wearing at Week 16

    Time frame: Baseline, Week 16

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  23. Change From Baseline in Sedentary Time Wearing at Week 17

    Time frame: Baseline, Week 17

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  24. Change From Baseline in Sedentary Time Wearing at Week 18

    Time frame: Baseline, Week 18

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  25. Change From Baseline in Sedentary Time Wearing at Week 19

    Time frame: Baseline, Week 19

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  26. Change From Baseline in Sedentary Time Wearing at Week 20

    Time frame: Baseline, Week 20

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  27. Change From Baseline in Sedentary Time Wearing at Week 21

    Time frame: Baseline, Week 21

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  28. Change From Baseline in Sedentary Time Wearing at Week 22

    Time frame: Baseline, Week 22

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  29. Change From Baseline in Sedentary Time Wearing at Week 23

    Time frame: Baseline, Week 23

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

  30. Change From Baseline in Sedentary Time Wearing at Week 24

    Time frame: Baseline, Week 24

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Secondary outcomes

  1. Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6

    Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

    The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer patients' QOL, and it's composed of five multi-item functional subscales (physical [P], role [R], emotional [E], cognitive [C], and social [S] functioning [F]). Response to functional scales is based on a 4-point Likert scale and ranges from 'not at all' to 'very much'. Responses to all functional sub-scales were converted to a 0 to 100 scale. For functional sub-scale, higher scores indicated a better level of functioning.

  2. Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6

    Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

    The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer patients' QOL, and it's composed of three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). Response to symptom sub-scales is based on a 4-point Likert scale and a higher score indicated more severe symptoms. Responses to all symptom sub-scales were converted to a 0 to 100 scale. A higher score indicated more severe symptoms. A 10-point or higher change in scores from baseline was considered clinically significant.

  3. Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

    Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

    Total estimated steps taken per week were reported in this outcome measure.

  4. Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

    Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

    Total estimated number of minutes of moderate or higher (moderate to vigorous) physical activity per date as calculated using the Staudenmayer '15 technique were reported in this outcome measure.

  5. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events

    Time frame: From start of study treatment up to 28 days after last dose of treatment (Up to 28 weeks)

    AE= any untoward medical occurrence,could therefore be any unfavorable,unintended sign (including an abnormal laboratory finding),symptom,or disease,whether or not related to the participant's participation in the study. An SAE was any untoward medical occurrence at any dose that:resulted in death;was life-threatening(LT);required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent or significant disability/incapacity(substantial disruption of the ability to conduct normal life functions);resulted in congenital anomaly/birth defect;or an important medical event. AEs were graded(G) according to Common Terminology Criteria for AE(CTCAE) version 4.03. G3 (Severe AE),G4 (LT consequences;urgent intervention indicated),G5 (Death related to AE). TEAEs were those events with onset dates occurring during the on-treatment period (the time from start of study treatment up to 28 days after last dose). Relatedness was based on the investigator's judgement.

  6. Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

    The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on fatigue severity on a five-point Likert scale. For Fatigue Severity (FS) scoring was as follows: 0= None, 10= Mild, 20= Moderate, 30= Severe, 40= Very Severe.

  7. Number of Participants According to Fatigue Interference Based on PRO-CTCAE

    Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

    The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on fatigue interference on a five-point Likert scale. For Fatigue Interference (FI) scoring was as follows: 0= Not at all/None/Never, 1= A Little bit, 2: Somewhat, 3= Quite a bit, 4= Very much.

  8. Number of Participants According to Pain Severity Based on PRO-CTCAE

    Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

    The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain severity on a five-point Likert scale. For Pain Severity (PS) scoring was as follows: 0= None, 10= Mild, 20= Moderate, 30= Severe, 40= Very Severe.

  9. Number of Participants According to Pain Interference Based on PRO-CTCAE

    Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

    The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain interference on a five-point Likert scale. For Pain Interference (PI) scoring was as follows: 0= Not at all/None/Never, 1= A Little bit, 2: Somewhat, 3= Quite a bit, 4= Very much.

  10. Number of Participants According to Pain Frequency Based on PRO-CTCAE

    Time frame: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

    The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain frequency on a five-point Likert scale. For Pain Frequency (PF) scoring was as follows: 0= None, 1= Rarely, 2: Occasionally, 3= Frequently, 4=Almost Constantly.

  11. Sedentary Time Before and After Disease Progression: Group 1 and 2 Pooled

    Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)

    Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device 10 hours or longer during a day except for bedtime. Disease progression was defined as greater than (>) 25% increase in sum of longest diameter of target lesions compared to baseline.

  12. Steps Taken Before and After Disease Progression: Group 1 and 2 Pooled

    Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)

    Total estimated steps taken per week were reported in this outcome measure. Disease progression was defined as >25% increase in sum of longest diameter of target lesions compared to baseline.

  13. MVPA Before and After Disease Progression: Group 1 and 2 Pooled

    Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)

    Total estimated number of minutes of Moderate or higher (moderate to vigorous) physical activity per date as calculated using the Staudenmayer '15 technique were reported in this outcome measure. Disease progression was defined as >25% increase in sum of longest diameter of target lesions compared to baseline.

  14. EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled

    Time frame: Before and after disease progression during the observation period (maximum up to 24 weeks)

    The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL,it's composed of five multi-item functional subscales (physical [P],role [R],emotional [E],cognitive [C], and social [S] functioning [F], three multi-item symptom scales (fatigue,nausea/vomiting,pain) a GHS/QOL subscale,and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation,diarrhea,and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Response to functional scales is based on a 4-point Likert scale and ranges from 'not at all' to 'very much'. Responses to GHS/QOL and all functional sub-scales were converted to a 0 to 100 scale. For GHS/QOL and functional subscale, higher scores indicated a better QOL and better level of functioning, respectively. Disease progression was defined as >25% increase in sum of longest diameter of target lesions compared to baseline.

  15. Number of Participants With Treatment Satisfaction

    Time frame: Day 15 of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle = 4 weeks)

    Treatment satisfaction was evaluated with single item question (eg,"How satisfied are you with your current breast cancer treatment?") using the smart phone application. Responses were provided on a four-point Likert scale (dissatisfied, neutral, satisfied, very satisfied).

  16. Number of Participants According to Starting Dose of Palbociclib Treatment

    Time frame: Baseline

    Number of participants according to starting dose of palbociclib treatment (125 milligrams [mg], 100 mg and 75 mg) is reported in this outcome measure. Baseline values are those measured between enrollment and the day before treatment start.

  17. Number of Participants Who Had Any Palbociclib Dose Reduction

    Time frame: Up to 24 Weeks

  18. Number of Participants Who Had Any Palbociclib Dose Interruption

    Time frame: Up to 24 Weeks

  19. Number of Participants With Cycle Delay in Palbociclib Treatment

    Time frame: Up to 24 Weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Japan Breast Cancer Research Group

Registry information

Official study title

Prospective, Multicenter, Observational Study to Evaluate Patient-reported Outcome and Physical Activity Using Smartphone-based Application and Wearable Device in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy

Acronym: JBCRG-26

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2021
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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